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Prediction Model fo Screening and Diagnosis of Prostate Cancer in PSA Gray Zone Based on Serum PHI Combined With TPV

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Prostate Cancer
PSA

Treatments

Diagnostic Test: Transperineal prostate biopsy
Diagnostic Test: p2PSA
Diagnostic Test: Ultrasonic parameters

Study type

Observational

Funder types

Other

Identifiers

NCT04251546
XH-20-002

Details and patient eligibility

About

Prostate cancer (PCa) is a high incidence tumor of elderly men. In recent years, its incidence has rapidly increased in China. Serological examination of prostate-specific antigen (PSA) is particularly important in the early diagnosis of PCa, but its specificity is lower in gray areas with PSA between 4-10 ng / ml. Proposition of prostate health index (PHI) strengthens the specificity of PSA gray area prostate cancer diagnosis, but the composition of the index only relies on serological examination, neglects imaging indicators, and cannot be comprehensively evaluated. Based on the preliminary basis of PHI research in the undergraduate department, combined with ultrasound imaging indicators of total prostate volume (TPV), this research group prospectively analyzed the efficacy of PHI combined with TPV to predict prostate cancer in patients with PSA gray areas, and established an improved version of PHI-TPV combination. The prediction model mPHI assesses the sensitivity of the new model to predict the risk of prostate cancer in the Chinese population, provides data support for puncture decisions of middle-aged and elderly male patients in the gray area of PSA in China, and provides reference and guidance for the individualized prevention and treatment of prostate cancer.

Enrollment

80 estimated patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patient> 45 years of age
  2. Abnormal serum PSA
  3. Prostate nodules found by DRE
  4. Abnormal MRI or TRUS finding

Exclusion criteria

  1. Incomplete medical history
  2. Poor quality of serum samples
  3. Bacterial acute prostatitis diagnosed within 3 months before biopsy 4.5α reductase inhibitors, anabolic steroids, or antiandrogen drugs taken within 12 months before biopsy

5.Previous prostate biopsy history.

Trial design

80 participants in 1 patient group

Observational group
Description:
Patients with suspected prostate cancer with a PSA test value of 4-10 ng / mL
Treatment:
Diagnostic Test: Transperineal prostate biopsy
Diagnostic Test: Ultrasonic parameters
Diagnostic Test: p2PSA

Trial contacts and locations

1

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Central trial contact

Yongjiang Yu, MD.

Data sourced from clinicaltrials.gov

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